Cleared Traditional

K905347 - HAGIE PIN

K905347 is an FDA 510(k) clearance for HAGIE PIN, manufactured by O'Tec Corp.. The device is a Class 2 Orthopedic device with product code JDW cleared through the Traditional 510(k) pathway after a 37-day FDA review.

K905347 · O'Tec Corp. · Orthopedic device
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Jan 1991
Decision
37d
Days
Class 2
Risk

K905347 is an FDA 510(k) clearance for the HAGIE PIN. Classified as Pin, Fixation, Threaded (product code JDW), Class II - Special Controls.

Submitted by O'Tec Corp. (Memphis, US). The FDA issued a Cleared decision on January 4, 1991 after a review of 37 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3040 - the FDA orthopedic device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all O'Tec Corp. devices

FDA 510(k) Submission Details - K905347

510(k) Number K905347 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received November 28, 1990
Decision Date January 04, 1991
Days to Decision 37 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
85d faster than avg
Panel avg: 122d · This submission: 37d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JDW Device Classification - Class 2, Special Controls

Product Code JDW Pin, Fixation, Threaded
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3040
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Orthopedic devices follow this clearance model.

Regulatory Peers - JDW Pin, Fixation, Threaded

All 60
Devices cleared under the same product code (JDW) and FDA review panel - the closest regulatory comparables to K905347.
CANNULATED PLUS HIP SCREW
K952640 · Wrightmedicaltechnologyinc · Jul 1995
CROSS PIN SCREW SYSTEM
K946228 · Depuy, Inc. · May 1995
ORTHOPEDIC THREADED PIN FIXATION
K932349 · Osteomed Corp. · Mar 1994
RUSH PIN
K903261 · Onyx Medical Corp. · Jul 1990
STEINMAN PIN, THREAD
K903266 · Onyx Medical Corp. · Jul 1990
FIXATOR PIN (EXTERNAL)
K881511 · Orthopedic Systems, Inc. · Jun 1988